In Wakayama Prefecture, Japan, authorities carried out an inspection of Kobayashi Pharmaceutical’s beni-koji red yeast rice factory. This action followed reports of deaths and hospitalizations associated with the product, which had been produced at a facility in Osaka that had ceased operations due to outdated machinery. Additional ingredients were supplied to the Wakayama factory from January onwards, and the company expressed its willingness to cooperate with authorities to determine the cause of the issues promptly.
Health officials from the Japanese Ministry of Health conducted an inspection at the factory on February 31, aiming to investigate the presence of puberulic acid in the products and its potential toxicity. The company had previously suggested that this natural compound found in green mold during rice fermentation could be linked to adverse effects. However, it was also acknowledged that the beni-koji production line did not meet Good Manufacturing Practices (GMP) standards.
During a press conference on March 29, President and CEO Akihiro Kobayashi issued an apology for the problems faced by users and promised thorough investigations to identify the cause and implement necessary measures. The company’s products are distributed in various countries in Asia, including China and Taiwan, where sales have been halted following health concerns in Japan. As of March 27, five deaths and over 115 cases linked to consumption of beni-koji products have been reported in Japan.
The Food Safety Department of the Ministry of Health emphasized that these products were not authorized for sale in Vietnam and cautioned against purchasing them through unofficial channels. Any sightings of these products should be reported to authorities under Vietnam’s laws for appropriate action. The investigation into manufacturing process will continue to assess product safety and its impact on public health.
